1. Field of the Invention
This invention relates generally to medical devices. It relates particularly to a holistically integrated ultrasonic system and process for examining, mapping, diagnosing, and treating diseases of the prostate gland in a male human, especially prostate cancer.
2. Description of the Related Art
Prostate gland problems are widespread in the male population, especially the older male population. In particular, benign prostatic hyperplasia (BPH) and prostate cancer are all-too-common in men over 50 years of age. Indeed, prostate cancer is the cause of death in about 40,000 men each year, making it the Number Two cancer killer of men in the United States, second only to lung cancer. However, if prostate cancer is detected early and treated effectively, the chance of survival of one afflicted with this disease improves significantly. Unfortunately, methods of detection of prostate cancer employed today are found seriously wanting, even in the hand of the highly skilled, as many early stage cancers still go undetected and/or an undue multiplicity of painful biopsies are required for diagnosis.
In an attempt to enhance the efficiency and efficacy of methods and systems of detection of prostate cancer, medical science turned to ultrasonics, and for several years ultrasonics has been applied in accomplishing diagnostic examinations of the prostate gland of the human male. As examples of advances made in this and related are as are the following U.S. Pat. Nos. 5,282,472; 5,398,690; 5,810,731; 5,952,828; 5,178,147; 5,919,139; 5,952,828; and 6,165,128. Notwithstanding the achievements of these inventions, the fact remains that no examining system or technique presently exists which provides the high degree of resolution and the accompanying precision which are absolutely necessary for an accurate diagnosis of prostate cancer, nor is the required repeatability of result achieved. Moreover, no technique, method, or system of the related art provides a holistically integrated ultrasonic approach which combines examining, mapping, diagnosing, and treating diseases of the prostate gland, especially cancer, in a male human, with a minimum of physical and mental discomfort.
It is accordingly a primary object of the present invention to obviate the disadvantages presented by systems and processes of the Related Art. This object is achieved, and attending benefits are acquired, by the provision of a holistically integrated ultrasonic system for examining, mapping, diagnosing and treating diseases of the prostate gland in a male human.
The first factor in the holistically integrated ultrasonic system of the present invention is means to reliably detect and map prostate cancer in early stages. However, success in the area of reliable detection and mapping will not be readily accepted and utilized appropriately, unless a second factor is integrated into the system. The second factor (a highly reliable follow-on biopsy or the application of a precisely guided reactive sensor to cancer tissue contact) is the means to reliably confirm the findings of the first factor.
Delivery of an integrated system comprising the above two factors yields opportunities to treat prostate cancer at times when the probability for successful treatment is high. Therefore, the present invention includes a third factor that provides for vastly improving the results of today""s treatment modalities, as well as the introduction of new, effective, and patient friendly treatment modalities for prostate cancer in early stages.
To achieve consistent and reliable detection across the total spectrum of prostate cancer conditions, the present invention includes a fourth factor, which is an expert system, which provides the ability to utilize and integrate, in real time, data from several sensor inputs with several analytical techniques (this is not feasible with the limitations of human performance, but is achievable with the present expert system). The fifth factor in the instant system is cost-effectiveness to lower the overall health care cost associated with prostate cancer detection and treatment.
In the operation of the holistically integrated ultrasonic system according to the present invention, the following are applied:
(1) More than one ultrasonic sensor package working together in an integrated manner;
(2) Multiple analytical techniques;
(3) A constant, effective medium for superior ultrasonic sensor performance;
(4) High frequency ultrasound versus the lower frequency used in today""s technology;
(5) Level-of-suspicion prostate cancer mapping;
(6) An automated slave biopsy subsystem with precision targeting; and
(7) A design philosophy to create a friendly patient and doctor experience.
As a result, the present invention has the capacity to:
(1) Provide early prostate cancer detection when the cancer or cancers are small;
(2) Automatically and clearly identify what has changed between successive examinations;
(3) Track treatment impact in real time for certain treatment modalities, and for others, to provide tracking over different time periods;
(4) Provide new, patient friendly, treatment options;
(5) Produce the matching of system output with pathology findings as proof of system performance.